A.
Clinical & Scientific Advisory
For pharmaceutical, biotech and other life sciences companies
Independent clinical assessment of emerging therapies, clinical concepts and medical innovations.
Focus areas
- Critical appraisal of clinical trial concepts and study designs
- Assessment of patient selection, comparators and clinical endpoints
- Evaluation of clinical relevance and meaningful therapeutic benefit
- Interpretation of scientific findings in the context of real-world clinical practice
- Consideration of treatment alternatives, healthcare resources and economic implications
- Independent specialist input for pharmaceutical, biotech and other life sciences companies
Guiding questions
- Does the study design address the relevant clinical question?
- Are population, comparator and endpoints appropriate?
- Does a statistically significant result translate into meaningful clinical benefit?
- Is the expected benefit proportionate to the resources required?
Practical background
I have designed my own research project, applied for ethics committee approval, conducted the study and compiled its results, and I have supervised doctoral students. I regularly complete GCP/AMG investigator training and have worked as a sub-investigator in clinical trials. This gives me a practical understanding of how studies are designed, run and analysed.
Independent clinical judgement. Not formal health-economic modelling, regulatory consulting, systematic evidence reviews or investment due diligence.
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